Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial

Home Study of Subjects With Obstructive Sleep Apnea Who Have Previously Completed an In-Lab Continuous Negative External Pressure (cNEP) Titration and Were Considered to be Responders

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03108417

Enrollment

Registered

2017-04-11

Start date

2017-10-31

Completion date

2018-09-30

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief summary

This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two weeks in a home setting. It will also be determined whether two weeks of home use of cNEP is associated with any adverse events.

Interventions

DEVICEcontinuous negative external pressure

continuous negative external pressure will be applied to the anterior neck at night

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to 70 Years

Healthy volunteers

Inclusion criteria

* must have completed study SOM-012 and been categorized as a responder * the subject agrees to participation by signing an informed consent statement

Exclusion criteria

* medical or social circumstances have changed since participation in SOM-012 such that continued use of cNEP may provide questionable benefit or associated with increased risk

Design outcomes

Primary

Measure	Time frame	Description
Reduction in baseline apnea hypopnea index from baseline	End of Week 2 of home use	Reduction in apnea hypopnea index (AHI) from the baseline value of \>50% and also \<15/hr

Secondary

Measure	Time frame	Description
Collection of adverse events	two week study period	Collection of adverse events
Apnea hypopnea index, as measured by home sleep testing	two weeks	Comparison of AHI from home sleep testing in this study to those of the polysomnogram (PSG) in SOM-012

Other

Measure	Time frame	Description
Clinical global impression of cNEP experience	end of week two of home use	Assessment of the tolerability of cNEP to the subject via a clinical global impression scale
Bed partner's views of cNEP via a clinical global impression scale	end of two weeks of home use	Determination of the bed partner's views of the subject using cNEP in the home setting using a clinical global impression scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026